Validation Services

 

SQM, Inc. provides validation and verification testing services for software, including product, quality system, manufacturing and off-the-shelf components through the following Regulatory Services:  

 

(SQM tests products to their specifications, recommending modifications to increase their performance and compliance to the FDA’s Quality System Regulation and the European Medical Device Directive. Manufacturing and Quality Systems are validated for their intended use. Purchased software packages, or off-the-shelf software may be validated for integration into a product or for internal system support.)

PRODUCT VALIDATION AND VERIFICATION

Black Box Testing: The FDA requires that all products be fully validated prior to distribution. SQM validates products to their specification, performing "black box" testing in the configuration required. SQM recommends improvements to the specification and to supporting processes necessary to ensure full validation.

Hardware / Software Integration: Quality System Regulations expect validation of software in conjunction with specified hardware configuration. SQM performs these validations across multiple configurations, producing the necessary results to ensure proper functionality.

Unit Testing: SQM performs testing of separately testable elements specified in the design of a computer software element, such as units, components, or modules.

Off-the-Shelf Software Testing: SQM executes testing necessary to validate purchased software for its intended use. This software may be integrated into a product or support internal quality system needs.

Automated Test Script Validation: SQM validates test scripts used during product testing to verify their correct operation. SQM also generates and modifies automated test scripts.

SYSTEM VALIDATION

System Testing: SQM validates systems comprised of multiple devices, in client/server or other networked configurations. SQM not only validates the applications specified for the system, but also validates interface capabilities, such as DICOM, HL-7, and other medical device specific protocols.

PROCESS VALIDATION

Manufacturing Systems: SQM validates software used to support medical manufacturing in many diverse scenarios from tracking to process control.

Quality Systems: SQM assists clients in validating their quality systems to satisfy all medical device standards.

 

SQM Inc. can provide various levels of support individually tailored

for your special needs!


Software Quality Management, Inc. (SQM), 2 Southerly Court, Suite 603, Towson, MD, 21286, USA, 410-339-5307 (v), 

410-823-8019 (f), info@sqminc.com, copyright SQM, 1997-2002, Last modified: November 18, 2009